Evaluation of the Safety and Effectiveness of the vPatch Device
- Conditions
- Premature Ejaculation
- Interventions
- Device: Active Device (vPatch)Device: Sham Device (vPatch)
- Registration Number
- NCT03942367
- Lead Sponsor
- Virility Medical Ltd.
- Brief Summary
Multi-center, international, prospective, randomized, double-blind, two-arms, sham-controlled, first-in-human clinical investigation.
The Patients will be allocated to one of the following groups:
* Group A (Active Device Group): Patients will receive a fully functioning vPatch device, pre-configured to deliver stimulation intensity according to the subjective motor threshold intensity reported by the Patients. Pre-configured stimulation intensity cannot be changed by the Patient.
* Group B (Sham Device Group): Patients will receive a vPatch device pre-configured to deliver the sensory electrical stimulation according to the subjective sensory threshold that is ineffective for muscle activation. Pre-configured stimulation intensity cannot be changed by the Patient.
The study will start with a Screening Visit (Visit 1), when potential Patients complaining of PE will be informed about the investigation and its objectives. If they agree to participate, after signing a valid Informed Consent Form they will undergo a full medical history and physical examination and will be selected according to eligibility criteria except IELT (which will be examined at the next visit).
The primary objective of this study is to assess the safety profile of the vPatch device and its effectiveness in delaying ejaculation when used in Patients suffering of PE.
The secondary objectives of this study are:
* To assess the Patient's perception of the ease of use of the vPatch device and treatment, through the use of a dedicated questionnaire (Usability Questionnaire).
* To assess the Patient's perception of the changes in his Premature Ejaculation Profile (PEP) under different aspects with the use of device, through the use of a dedicated questionnaire (Control and Distress Domains of the Premature Ejaculation Profile (PEP) Questionnaire).
* To assess the Patient's perceived intensity of orgasm by using the vPatch device, through the use of a validated tool (Orgasmometer).
- Detailed Description
After the first visit the Patients will undergo a run-in Home Phase, during which they will be asked to have 4 sexual intercourse sessions with their female partners, in the privacy of their home, during which their partner will measure their intravaginal ejaculatory latency time (IELT) using a stopwatch.
After the run-in Home Phase the Patients will be requested to attend to the hospital (Visit 2) and the ones with a IELT value confirming their eligibility will be randomized in the trial (otherwise they will be excluded as Screening Failures).
Visit 2 will include three steps. Step 1: conditioning stimulation, delivered to the Patient's forearm muscles, aiming at familiarizing and adapting the Patient to transcutaneous electrical stimulation. Stimulation during Step 1 will be delivered using a CE approved TensMed S82 device. Following the conditioning stimulation, the Patient will undergo Step 2: incrementally increasing perineal stimulation, in order to identify the electrical intensity of his sensory and motor activation. The Patient will recognize motor activation as a muscle contraction, similarly to the voluntary induced muscle contraction when delaying urination. Step 2 will be repeated twice. Finally, the Patient will undergo Step 3: 10 to 15 minutes (according to Investigator's discretion) of continuous functional intensity stimulation, delivered to the Patient's perineum, aiming at demonstrating safety of prolonged stimulation. Stimulation during Steps 2 and 3 will be delivered using the investigational BLE (Bluetooth Low Energy)-enabled vPatch device. Furthermore, the Investigator will carefully instruct the Patient how to safely place the device, how to safely use of the device, and how to remove the device. During this visit the baseline assessments (see flow chart) will be carried out.
Following the Visit 2, the Home Phase will initiate, where the Patients will be asked to have 4 sexual intercourse sessions with their female partners, in the privacy of their home, during which their partner will measure their Intravaginal Ejaculatory Latency Time (IELT) using a stopwatch. The 4 sessions will include four IELT measurements, while the investigational BLE-disabled vPatch device is applied, pre-configured either delivering a functional stimulation to 40 Patients (Active Device Group) or sensory stimulation to 20 Patients (Sham Device Group). All Patients will be informed that the stimulation is not necessarily detectable. The Investigator will call the Patients every day during the first three days of the Home Phase to monitor the progression and to remind to fill in the 72 h Safety Questionnaire.
The Patients will be requested to return to the site (Visit 3) after 4 intercourse sessions with their female partners in order to undergo the assessments foreseen by protocol (see flow chart) and to return the filled questionnaires and the used device. This will be considered the End of Trial Visit.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A (Active Device Group) Active Device (vPatch) Patients will receive a fully functioning vPatch device, pre-configured to deliver stimulation intensity according to the subjective motor threshold intensity reported by the Patients. Pre-configured stimulation intensity cannot be changed by the Patient. Group B (Sham Device Group) Sham Device (vPatch) Patients will receive a vPatch device pre-configured to deliver the sensory electrical stimulation according to the subjective sensory threshold that is ineffective for muscle activation. Pre-configured stimulation intensity cannot be changed by the Patient.
- Primary Outcome Measures
Name Time Method Objective: change in IELT from baseline (V2) to the end of Home Phase Visit (V3). Up to 56 days Primary Endpoint of Device Performance
Subjective: proportion of patients reporting an improvement according to the Clinical Global Impression of Change (CGIC) measured at V3. Up to 56 days Primary Endpoint of Device Performance
Adverse events rate during the study period. All adverse occurrences (serious/non-serious or device-related/non device-related) will be recorded prospectively, categorized and evaluated for causality using defined criteria. Entire Study Period (up to 2,5 months) Primary Endpoint of Safety
- Secondary Outcome Measures
Name Time Method Evaluation of Patient's subjective outcome assessment of ease of use of the vPatch device and treatment during Home Phase. Entire Study Period (up to 2,5 months) Secondary Endpoint of Device Performance
Evaluation of Patient's subjective outcome assessment of the Premature Ejaculation Profile (PEP) from baseline (V2) to the end of Home Phase Visit (V3). Up to 56 days Secondary Endpoint of Device Performance
Evaluation of Patient's subjective outcome assessment of orgasmic intensity via Orgasmometer from baseline (V2) to the end of Home Phase Visit (V3). Up to 56 days Secondary Endpoint of Device Performance
Trial Locations
- Locations (3)
Urologia, Casa di Cura "Villa Donatello"
🇮🇹Sesto Fiorentino, Firenze, Italy
U.O.C. Urologia e Centro di litotrissia urinaria D.A.I. Nefrologia, urologia e chirurgia generale e dei trapianti di rene, anestesia e rianimazione, A.O.U. "Federico II" di Napoli
🇮🇹Napoli, Italy
Sexual Dysfunction Clinic, Rambam Medical Center
🇮🇱Haifa, Israel